Transcutaneous devices have application in many areas of medicine, these including such areas as bone stents or pins where it is necessary to stabilize fragments of a bone during a period of healing, medication-dispensing soft tissue implants such as those that require external access by the needle of a syringe, and neural interface devices that require both physical stability at an amputation and/or nerve injury site and an external electrical port to which a prosthesis may be attached. These unique and diverse requirements, of transcutaneous devices have presented long-standing challenges within the medical disciplines, in which they exist.
Most transcutaneous devices must satisfactorily address requirements at three levels, namely, bone interface stability, soft tissue stability, and suitable properties of an external portion thereof. Accordingly, in a successful transcutaneous device, it is necessary to obtain a stable, reliable and bacteria free interface to both the hard and soft tissue surfaces thereof.
In the field of peripheral nerve interface development to develop a stable, practically useful mechanism for obtaining motor information from lesioned peripheral nerves, conduct this information out of the body and effectively activate prosthetic motor devices requires a stable nerve and skeletal attachment interface and a transcutaneous access port.
Common problems in the existing transcutaneous ports include instability of the transcutaneous ports which results in detachment of the device from the nerves, or the site and microbial infiltration at the interface between the transcutaneous port and surrounding soft tissue, which also results in the detachment.
U.S. Pat. No. 5,607,607 (to Naiman et al.) teaches a transcutaneous implant which has a first and a second microtexturized surfaces provided on the outer circumferential surface of the implant, and separated by a barrier zone. The transcutaneous implant is to be implanted within soft issue in situ, and both microtexturized surfaces are used for enhancing integration of the implant with the soft tissue. This type of transcutaneous implant is not anchored into bone and has no involvement with bone tissue, and its stability in an amputation site is limited.
Therefore, there is a strong need in the field of peripheral nerve interface development for improved transcutaneous ports which enables integration of the device with surrounding soft tissue and bone tissue, hence, provides feasibility for long term use of the transcutaneous port in situ for providing electronic communication to prosthetic motor devices.